Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Gingivitis Clinical Trial

— POP  

Official title:

Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04634201
• Other study ID #: 2019_14
• Secondary ID: 2020-A02179-30
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Kevimy AGOSSA, MD
• Phone: 0320445962
• Email: kevimy.agossa[@]univ-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• adolescents aged 12 to 16 benefiting from social security coverage

• in good general health in brushing and taking treatments

• Have FODs

• who consent to the study and whose parents have given their consent

• suitable for orthodontic treatment in view of his oral state

Exclusion Criteria:

• inability to obtain informed consent

• use of another probiotic or toothpaste / antiseptic mouthwash = 1 month before inclusion

• allergy or hypersensibiliity to the active substance or to any of the excipients listed in the Gum® PerioBalance® user guide)

• no history of antibiotic therapy, antiseptic mouthwash = 1 month before inclusion

• medical contraindication (immunosuppression, pathology requiring prophylactic antibiotic therapy before dental care)

• physiological, pathological condition, medication or behavior that may have repercussions on the oral cavity (eg: pregnancy, diabetes, antiepileptics, tobacco)

• oral state requiring other priority care (untreated cavities, untreated active periodontitis, progressive recession)

Related Conditions & MeSH terms

• Gingivitis
• Periodontal Health

Intervention

Dietary Supplement:
• Oral probiotics (L. reuteri)
administration of probiotic containing tablets twice daily after tooth brushing for 3 months
• Placebo
administration of a placebo twice daily after tooth brushing for 3 months

Locations

Country	Name	City	State
France	Hop Salengro - Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Sunstar, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of gingival index (Löe Silness) between baseline and 6 months		At 6 months
Secondary	bleeding on probing (BOP) score (% of BOP sites)		At Baseline, at 3 months and 6 months
Secondary	plaque index (O'leary)		At Baseline, at 3 months and 6 months
Secondary	dysbiosis index	Shannon-weaver, alpha rarefaction, beta diversity	At Baseline, at 3 months and 6 months
Secondary	level of salivary markers of inflammation -		At Baseline, at 3 months and 6 months
Secondary	compliance level record		At Baseline, at 3 months and 6 months